Synopsis

To ensure safe reuse of surgical instruments in hospitals, the instruments are cleaned, maintained, packaged and sterilised in steam sterilisers after use. These sterilisers are checked annually to make sure they function properly. In 2013, RIVM identified some deficiencies in these validations. A follow-up study shows that professional organisations and validation companies have initiated actions to improve the validations. However, there may still be differences in the methods used. If these actions are observed, the validations will be performed better and will be more uniform.

It also appears that manufacturers and suppliers of steam sterilisers do not provide all information needed for the validations. They do not specify the type of medical device for which the steriliser is suited. They also did not show a complete list of the process specifications. This information is necessary to properly assess the validation measurements.

Since 2013, the trade associations drew up a field standard. The industry standard focuses on the organisational aspects of the validation and assists in setting up a statement of requirements. A thorough statement of requirements is important for clarity on which procedures are expected of the company that carries out the validation and how the results are reported and interpreted. In addition, the NEN guideline D6103b from 2006 is now being revised. It specifically details what the international ISO standard (17665 part 1) prescribes.